The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Dynasty Biofoam Shell.
| Device ID | K122382 |
| 510k Number | K122382 |
| Device Name: | DYNASTY BIOFOAM SHELL |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Dean Nachtrab |
| Correspondent | Dean Nachtrab WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | MBL |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-06 |
| Decision Date | 2012-10-22 |
| Summary: | summary |